Acute Respiratory FailureNCT01691222
Tracheostomy in ICU With a Double Lumen Endotracheal Tube
A study testing Double lumen endotracheal tube tracheostomy in people with Acute Respiratory Failure and Heart Failure, run by University of Genova at 2 sites in Italy.
Trial summary
Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Acute Respiratory Failure, Heart Failure, Neurological Disease
- What is being tested?
- Double lumen endotracheal tube tracheostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years and at least one of following criteria:
- prolonged endotracheal intubation
- prolonged mechanical ventilation
- difficult/prolonged weaning
- inability to protect the airway
Who cannot join
- infection of neck tissues
- previous surgical neck interventions
- recent surgical interventions or fracture of the cervical spine
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
University of Genoa
Genoa, Italy, 16132
Paolo Pelosi, Professor, + 39 0101 5553136, ppelosi@hotmail.com
Paolo Pelosi, Professor
- Recruiting
University of Naples "Federico II"
Naples, Italy, 80100
Giuseppe Servillo, Professor, +39 081 7463552, servillo@unina.it
Giuseppe Servillo, Professor
About this study
Official title: Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube
Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may:
- improve the ventilation of patients during the procedure,
- protect the posterior tracheal wall from damage related to the different step of tracheostomies,
- protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.
So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.
- Being tested
- Double lumen endotracheal tube tracheostomy
- Keywords
- Bedside percutaneous tracheostomy, Intensive Care Unit, Dedicated Double-lumen tube, Ineffective Airway Clearance, weaning failure
- Medical subject headings
- Heart Failure, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen endotracheal tube tracheostomyDevice
Also called International Patent n° PCT/IT2012/000154
Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube.
The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature.
| Study group | Role | What they receive |
|---|---|---|
| Double lumen endotracheal tube tracheostomy | Other | Tracheostomy with a dedicated double lumen endotracheal tube Receives: Device: Double lumen endotracheal tube tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gas-exchange
The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio
Measured: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)
Secondary outcomes (6)
change in arterial carbon dioxide
the investigator will perform an arterial blood gas to evaluate PaCO2
Measured: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in peak airway pressure
the investigator will record peak airway pressure
Measured: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in plateau airway pressure
the investigator will record plateau airway pressure
Measured: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in air-trapping
the investigator will record auto-PEEP at the of expiration as a measure of air-trapping
Measured: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
early complications
early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax,
Measured: in the first 24 hours from the end of the procedure
late complications
late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
Measured: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pelosi, University of Genova
- Investigators
- Paolo Pelosi, Professor, Study director, Universita degli Studi di GenovaGiuseppe Servillo, Professor, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691222
- Sponsor's protocol ID
- 90/12
- Status last verified
- Jul 2013
- First submitted
- 30 Aug 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632.
PubMed 16342657De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
PubMed 17588767King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
PubMed 18440435Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PubMed 20667153Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.
PubMed 20523214Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
PubMed 3996056Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345.
PubMed 9142576Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.
PubMed 2343371Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383.
PubMed 10334157Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab.
PubMed 19295287Vargas M, Pelosi P, Tessitore G, Aloj F, Brunetti I, Arditi E, Salami D, Kacmarek RM, Servillo G. Percutaneous dilatational tracheostomy with a double-lumen endotracheal tube: a comparison of feasibility, gas exchange, and airway pressures. Chest. 2015 May;147(5):1267-1274. doi: 10.1378/chest.14-1465.
PubMed 25375865
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT01691222
- Acronym / sponsor ID
- 90/12
- Keywords
- Bedside percutaneous tracheostomy, Intensive Care Unit, Dedicated Double-lumen tube, Ineffective Airway Clearance, weaning failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may:
- improve the ventilation of patients during the procedure,
- protect the posterior tracheal wall from damage related to the different step of tracheostomies,
- protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.
So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double lumen endotracheal tube tracheostomy | Other | Device: Double lumen endotracheal tube tracheostomyTracheostomy with a dedicated double lumen endotracheal tube |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years and at least one of following criteria:
- prolonged endotracheal intubation
- prolonged mechanical ventilation
- difficult/prolonged weaning
- inability to protect the airway
Key exclusion criteria (3 listed)
- infection of neck tissues
- previous surgical neck interventions
- recent surgical interventions or fracture of the cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double lumen endotracheal tube tracheostomyAlso: International Patent n° PCT/IT2012/000154Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube. The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature. | Device | Double lumen endotracheal tube tracheostomy |
Primary outcome
change in gas-exchange
Time frame: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)
The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio
6 secondary outcomes
change in arterial carbon dioxide
Time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in peak airway pressure
Time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in plateau airway pressure
Time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
change in air-trapping
Time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
early complications
Time frame: in the first 24 hours from the end of the procedure
late complications
Time frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Background: PubMed 16342657Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632.
- Background: PubMed 17588767De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
- Background: PubMed 18440435King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
- Background: PubMed 20667153Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
- Background: PubMed 20523214Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.
- Background: PubMed 3996056Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
- Background: PubMed 9142576Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345.
- Background: PubMed 2343371Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.
- Background: PubMed 10334157Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383.
- Background: PubMed 19295287Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab.
- Derived from this study: PubMed 25375865Vargas M, Pelosi P, Tessitore G, Aloj F, Brunetti I, Arditi E, Salami D, Kacmarek RM, Servillo G. Percutaneous dilatational tracheostomy with a double-lumen endotracheal tube: a comparison of feasibility, gas exchange, and airway pressures. Chest. 2015 May;147(5):1267-1274. doi: 10.1378/chest.14-1465.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pelosi, Professor study director
Universita degli Studi di Genova
Giuseppe Servillo, Professor study director
Federico II University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double lumen endotracheal tube tracheostomy in people with Acute Respiratory Failure and Heart Failure, run by University of Genova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pelosi, Professor (+39 010 555 3136, ppelosi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in gas-exchange (time frame: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691222, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.